Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada | NCT01100749

Studies
Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada

NCT01100749

Sponsor

University Health Network, Toronto

Status

Terminated

Last Update Posted

May 28, 2015Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Chronic Hepatitis C - Genotype 3

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Apr 7, 2010

First Submission Date that Met QC Criteria

Apr 7, 2010

First Posted Date

Apr 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6 known genotypes and within each there are several subtypes. Although all genotypes are distributed worldwide some are more common in certain countries and/or among certain populations.

Detailed Description

Genotype 3(G3) infection is the predominant type in South East Asia (Bangladesh, Pakistan, India and Sri Lanka). In addition, because of the "promiscuous exposure" to hepatitis C amongst injection drug users, it is not unusual for the latter to be infected with G3 as well. There are several subtypes of G3. Viral genotype has long been recognized as a major factor influencing the response to interferon-based therapy. Patients infected with G2 and G3 respond much better to current therapy with peginterferon and ribavirin than those infected with G1 and G4. Most studies have grouped patients with G2 and G3 together, with few published comparisons of rates of viral clearance between these two favourable genotypes.

More recently it has become evident that in all individuals with chronic hepatitis C, the presence of insulin resistance, with or without the accompanying metabolic syndrome, is a major factor which influencing the response to antiviral therapy in CHC.

Very recently it has been reported and confirmed by several sites worldwide that specific polymorphisms of the IL28 gene are closely correlated with response to antiviral therapy in genotype 1 CHC. Interestingly, the polymorphisms were also shown to segregate according to ethnicity and may explain, at least in part, the marked differences in treatment response between different ethnic groups.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Factors associated with treatment outcome in genotype 3 in CHC	To study how factors such as viral subtype, ethnicity, insulin resistance, IL28 genotype and severity of liver disease contribute to treatment response.	Within 12 weeks before starting treatment compared to end of treatment response

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infected with only genotype 3, hepatitis C
Treatment naïve before current course of therapy
Age 18 or older

Exclusion Criteria:

Under age 18
Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
Prior treatment for Hepatitis C aside from herbal remedies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult subjects across Canada with chronic hepatitis C, genotype 3 infection who are treatment naïve.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. E.J. Heathcote, MD, FRCP, FRCP(C)	University Health Network - Toronto Western Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto General Hospital - Dr. M. Sherman Liver Clinic		Toronto	Ontario	M5G 2C4	Canada
University Health Network - Toronto Western Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18184194	Background	Freshwater DA, O'Donnell K, Mutimer DJ. Inferior response of Asian vs non-Asian hepatitis C genotype 3 infection to combination antiviral therapy. J Viral Hepat. 2008 Feb;15(2):115-9. doi: 10.1111/j.1365-2893.2007.00899.x.
19675375	Background	Isharwal S, Misra A, Wasir JS, Nigam P. Diet & insulin resistance: a review & Asian Indian perspective. Indian J Med Res. 2009 May;129(5):485-99.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human